Clearance Summary
3M CLINPRO PROPHY PASTE, MODEL 12611 received FDA 510(k) clearance under submission number K990482, sponsored by Minnesota Mining and Mfg. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-05-13.
- Submission: K990482
- Applicant / Sponsor: Minnesota Mining and Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6030
- Decision date: 1999-05-13
Classification & Regulation
This clearance is catalogued under FDA product code EJR and 21 CFR 872.6030, within the Dental review panel as a Class I device.